Cleared Special

K191335 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191335 · Corinth Medtech, Inc. · Obstetrics & Gynecology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jun 2019

Decision

20d

Days

Class 2

Risk

K191335 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, V.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 6, 2019 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Corinth Medtech, Inc. devices

Submission Details

510(k) Number	K191335 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 17, 2019
Decision Date	June 06, 2019
Days to Decision	20 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

140d faster than avg

Panel avg: 160d · This submission: 20d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	HIH Hysteroscope (and Accessories)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 884.1690

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.